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1.
Asian J Endosc Surg ; 17(3): e13316, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38692584

ABSTRACT

BACKGROUND: According to several clinical trials for patients with rectal cancer, laparoscopic surgery significantly reduces intraoperative complications and bleeding compared with laparotomy and demonstrated comparable long-term results. However, obesity is considered one of the risk factors for increased surgical difficulty, including complication rate, prolonged operation time, and bleeding. METHODS: Patients with clinical pathological stage II/III rectal cancer and a body mass index of ≥25 kg/m2 who underwent laparotomy or laparoscopic surgery between January 2009 and December 2013 at 51 institutions participating in the Japan Society of Laparoscopic Colorectal Surgery were included. These patients were divided into major bleeding (>500 mL) group and minor bleeding (≤500 mL) group. The risk factors of major bleeding were evaluated by univariate and multivariate analyses. RESULTS: This study included 517 patients, of which 74 (19.9%) experienced major bleeding. Patient characteristics did not significantly differ between the two groups. The major bleeding group had a longer operative time (p < 0.001) and a larger tumor size than the minor bleeding group (p = 0.011). In the univariate analysis, age >65 years, laparotomy, operative time >300 min, and multivisceral resection were significantly associated with intraoperative massive bleeding. In the multivariate analysis, age >65 years (odds ratio [OR], 2.29; 95% confidence interval [CI], 1.13-4.82), laparotomy (OR, 20.82; 95% CI, 11.56-39.75), operative time >300 min (OR, 5.39; 95% CI, 1.67-132), and multivisceral resection (OR, 10.72; 95% CI, 2.47-64.0) showed to be risk factors for massive bleeding. CONCLUSION: Age >65 years, laparotomy, operative time >300 min, and multivisceral resection were risk factors for massive bleeding during rectal cancer surgery in patients with obesity.


Subject(s)
Blood Loss, Surgical , Laparoscopy , Obesity , Operative Time , Rectal Neoplasms , Humans , Rectal Neoplasms/surgery , Rectal Neoplasms/complications , Rectal Neoplasms/pathology , Male , Female , Obesity/complications , Aged , Japan/epidemiology , Risk Factors , Middle Aged , Laparoscopy/adverse effects , Blood Loss, Surgical/statistics & numerical data , Retrospective Studies , Aged, 80 and over , Laparotomy , Adult , Body Mass Index
2.
Ann Surg ; 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38557445

ABSTRACT

OBJECTIVE: To clarify the long-term oncological outcomes and postoperative anal, urinary, and sexual functions after laparoscopic surgery for clinical stage I very low rectal carcinoma located near the anal canal. SUMMARY BACKGROUND DATA: Laparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared to open surgery. METHODS: This single-arm, phase II trial included patients registered preoperatively from 47 institutions in Japan. The planned sample size was 300. The primary endpoint was the 3-year local recurrence rate. Anal, urinary, and sexual functions were evaluated using a prospective questionnaire. RESULTS: Three-hundred patients were registered between January 2014 and March 2017. Anus-preserving surgery was performed in 278 (93%), including 172 who underwent intersphincteric resection (58%) and 106 (36%) who underwent low anterior resection. The 3-year cumulative local recurrence rate was 6.3%. At 3 years postoperatively, 87% of patients used their own anus, and the median incontinence score improved from 12 at 3 months to 8 at 3 years. Only 5% of patients had severe incontinence (incontinence score of 16 points). Postoperative urinary function evaluation showed that International Prostate Symptom Score and Overactive Bladder Symptom Score decreased 1 week after surgery, but recovered to preoperative level 1 month after surgery. International Consultation on Incontinence Questionnaire-Sort Form remained almost stable after surgery. Sexual function evaluation using the International Index of Erectile Function-5 and International Index of Erectile Function-15 revealed that the patients had deteriorated 3 months after surgery but had recovered only slightly by 6 months. CONCLUSIONS: Laparoscopic surgery achieves feasible long-term oncological outcomes and a high rate of anus preservation with moderate anal function, and an acceptable incontinence score. While urinary function recovered rapidly, sexual function showed poor recovery.

4.
Ann Gastroenterol Surg ; 8(2): 273-283, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38455487

ABSTRACT

Aim: The aim of this study was to clarify the significance of resection of ovarian metastases from colorectal cancer and to identify the clinicopathologic characteristics. Methods: In this multicenter retrospective study, we evaluated data on ovarian metastases from colorectal cancer obtained from patients at 20 centers in Japan between 2000 and 2014. We examined the impact of resection on the prognosis of patients with ovarian metastases and examined prognostic factors. Results: The study included 296 patients with ovarian metastasis. The 3-y overall survival rate was 68.6% for solitary ovarian metastases. In all cases of this cohort, the 3-y overall survival rates after curative resection, noncurative resection, and nonresection were 65.9%, 31.8%, and 6.1%, respectively (curative resection vs noncurative resection [P < 0.01] and noncurative resection vs nonresection [P < 0.01]). In the multivariate analysis of prognostic factors, tumor size of ovarian metastasis (P < 0.01), bilateral ovarian metastasis (P = 0.01), peritoneal metastasis (P < 0.01), pulmonary metastasis (P = 0.04), liver metastasis (P < 0.01), and remnant of ovarian metastasis (P < 0.01) were statistically significantly different. Conclusion: The prognosis after curative resection for solitary ovarian metastases was shown to be relatively favorable as Stage IV colorectal cancer. Resection of ovarian metastases, not only curative resection but also noncurative resection, confers a survival benefit. Prognostic factors were large ovarian metastases, bilateral ovarian metastases, the presence of extraovarian metastases, and remnant ovarian metastases.

5.
In Vivo ; 38(2): 807-818, 2024.
Article in English | MEDLINE | ID: mdl-38418105

ABSTRACT

BACKGROUND/AIM: The extent of lymphadenectomy appropriate for patients with cT2 colorectal cancer (CRC) remains controversial. This study was conducted to compare the survival outcomes of patients with cT2 CRC after D3 or D2 lymph node dissection (LND). PATIENTS AND METHODS: Qualifying subjects (N=590) had undergone radical colorectal resections for cT2 CRC and were grouped according to tumor histological type as either well-differentiated (WDA) or non-well-differentiated (nWDA) adenocarcinoma. Each group was further stratified into D3 or D2 LND according to the extent of lymph node dissection. Propensity score matching (PSM) was applied to balance potential confounding factors, and identify independent prognostic risk factors using Cox regression analysis. Primary outcome measures were overall survival (OS), cancer-specific survival, (CSS) and relapse-free survival rate (RFS). RESULTS: Prior to PSM, OS and CSS differed significantly (p=0.001 and p=0.021, respectively) for D3 and D2 LND subsets in the nWDA group. Estimated hazard ratios (HRs) for OS and CSS were 3 [95% confidence interval (CI)=1.3-6.8; p=0.0084] and 3.2 (95%CI=1-10; p=0.047), respectively, in the D3 LND subset. After matching, significant differences in OS (p=0.007) and CSS (p=0.012) were also observed, with corresponding estimated HRs of 4 (95%CI=1.2-14; p=0.028) and 16 (95%CI=1.2-220; p=0.034). In the WDA group, D2 and D3 LND procedures displayed similar favorable prognoses before and after matching. Postoperative complications emerged as independent risk factors for prognosis in the WDA group of patients with cT2 CRC. CONCLUSION: D3 LND improved survival outcomes in patients with non-well-differentiated cT2 CRC. In patients with well-differentiated cT2 adenocarcinoma, D3 LND was preferred to reduce perioperative complications.


Subject(s)
Adenocarcinoma , Colorectal Neoplasms , Humans , Neoplasm Recurrence, Local/pathology , Lymph Node Excision/methods , Colorectal Neoplasms/pathology , Adenocarcinoma/pathology , Prognosis , Lymph Nodes/pathology , Retrospective Studies , Neoplasm Staging
9.
Anticancer Res ; 43(12): 5681-5688, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38030181

ABSTRACT

BACKGROUND/AIM: This study investigated the significance of lymph node metastasis (LNM) in patients with pT2 colorectal cancer (CRC). PATIENTS AND METHODS: This retrospective cohort study was conducted at a high-volume cancer center in Japan and targeted all qualifying patients (n=617) with radically resected pT2 CRC. Subjects were stratified by the presence (LNM+) or absence (LNM-) of LNM to compare cancer-specific survival (CSS) and relapse-free survival (RFS) rates before and after propensity score matching. RESULTS: There were 168 (27.2%) and 449 (72.8%) patients in the LNM+ and LNM- groups, respectively. Tumors in the LNM+ (vs. LNM-) group were more often less differentiated (Poor/Sig/Muc: 26.2% vs. 18.5%; p=0.035); more inclined to lymphatic (45.2% vs. 21.4%; p=0.000), vascular (64.9% vs. 44.8%; p=0.000), or neural (7.7% vs. 3.3%; p=0.019) invasion; and yielded more (≥12) harvested lymph nodes (94.0% vs. 85.5%; p=0.004). Although similar in terms of 5-year CSS (LNM-, 98.7%: LNM+, 95.8%; p=0.117), RFS in the LNM- (vs. LNM+) group was found to be significantly better (95.3% vs. 88.7%; p=0.003). After matching, RFS in the LNM- (vs. LNM+) group remained significantly better (95.4% vs. 88.7%; p=0.027). Recurrence was more likely in the LNM+ (vs. LNM-) group (pre-matching: 13.1% vs. 5.6%, p=0.002; post-matching: 12.4% vs. 5.2%, p=0.027), primarily occurring as liver metastases (pre-matching: 8.3% vs. 1.1%, p=0.002; post-matching: 7.8% vs. 1.3%, p=0.006). CONCLUSION: Lymph node metastasis does not affect CSS after radical resection of pT2 CRC, but vigilance for liver metastasis is essential. Downstaging of T2N+ CRC from stage IIIA to stage IIA is warranted.


Subject(s)
Colorectal Neoplasms , Humans , Prognosis , Colorectal Neoplasms/pathology , Retrospective Studies , Lymphatic Metastasis/pathology , Neoplasm Recurrence, Local/pathology , Lymph Nodes/pathology , Neoplasm Staging
10.
BMC Gastroenterol ; 23(1): 339, 2023 Oct 02.
Article in English | MEDLINE | ID: mdl-37784019

ABSTRACT

BACKGROUND: Fluoropyrimidine-based postoperative adjuvant chemotherapy is globally recommended for high-risk stage II and stage III colon cancer. However, adjuvant chemotherapy is often associated with severe adverse events and is not highly effective in preventing recurrence. Therefore, discovery of novel molecular biomarkers of postoperative adjuvant chemotherapy to identify patients at increased risk of recurrent colorectal cancer is warranted. Autophagy (including mitophagy) is activated under chemotherapy-induced stress and contributes to chemotherapy resistance. Expression of autophagy-related genes and their single-nucleotide polymorphisms are reported to be effective predictors of chemotherapy response in some cancers. Our goal was to evaluate the relationship between single-nucleotide variants of autophagy-related genes and recurrence rates in order to identify novel biomarkers that predict the effect of adjuvant chemotherapy in colorectal cancer. METHODS: We analyzed surgical or biopsy specimens from 84 patients who underwent radical surgery followed by fluoropyrimidine-based adjuvant chemotherapy at Saitama Medical University International Medical Center between January and December 2016. Using targeted enrichment sequencing, we identified single-nucleotide variants and insertions/deletions in 50 genes, including autophagy-related genes, and examined their association with colorectal cancer recurrence rates. RESULTS: We detected 560 single-nucleotide variants and insertions/deletions in the target region. The results of Fisher's exact test indicated that the recurrence rate of colorectal cancer after adjuvant chemotherapy was significantly lower in patients with the single-nucleotide variants (c.1018G > A [p < 0.005] or c.1562A > C [p < 0.01]) of the mitophagy-related gene PTEN-induced kinase 1. CONCLUSIONS: The two single-nucleotide variants of PINK1 gene may be biomarkers of non-recurrence in colorectal cancer patients who received postoperative adjuvant chemotherapy.


Subject(s)
Colorectal Neoplasms , Neoplasm Recurrence, Local , Humans , Retrospective Studies , Neoplasm Recurrence, Local/genetics , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Biomarkers , Chemotherapy, Adjuvant , Nucleotides/therapeutic use , Neoplasm Staging , Fluorouracil/therapeutic use , Biomarkers, Tumor/genetics , PTEN Phosphohydrolase/genetics
11.
Anticancer Res ; 43(9): 4169-4177, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37648329

ABSTRACT

BACKGROUND/AIM: The purpose of this study was to elucidate the status and clinical significance of skip lymph node metastasis (LNM) in colorectal cancer. PATIENTS AND METHODS: This is a retrospective cohort study from a high-volume cancer center in Japan. A total of 1,060 patients with primary stage III colorectal cancer (CRC) underwent radical resection were included in the study and divided into skip LNM (LNM) (skip+) and non-skip LNM (skip-) groups. Propensity score matching was used to balance potential confounding factors. The cancer-specific survival (CSS) and relapse-free survival rate (RFS) between the two groups before and after matching were evaluated. RESULTS: Before matching, patients in the skip+ group had a greater number of LNM (pN2: 48.3% vs. 31.1%; p<0.001), more pathological stage IIIC (43.2% vs. 17.6%; p<0.001), and a higher rate of recurrence (38.1% vs. 25.8%; p=0.0045). Consequently, the CSS (p=0.034) and RFS (p=0.005) were worse compared to the skip- group. However, after matching, there were no significant differences in prognosis for CSS (p=0.529) and RFS (p=0.515). In multivariate analysis, skip+ was not an independent risk factor for prognosis. However, the skip+ LNM group was more likely to have local lymph node recurrence. CONCLUSION: Skip+ LNM was more likely to happen in later stage CRCs, leading to significantly poorer survival outcomes. However, when all background factors were matched, the prognosis of the skip+ group was not worse. Surgeons need to be more alert to the possibility of local recurrence in patients with skip LNM.


Subject(s)
Clinical Relevance , Colorectal Neoplasms , Humans , Lymphatic Metastasis , Retrospective Studies , Colorectal Neoplasms/surgery , Japan
12.
BMC Surg ; 23(1): 155, 2023 Jun 10.
Article in English | MEDLINE | ID: mdl-37301966

ABSTRACT

PURPOSE: We have performed a single stapled anastomosis with double purse-string sutures as a Trans anal Total Mesorectal Excision (TaTME) reconstruction for low rectal cancer. We report an attempt to control local infection and reduce anastomotic leakage (AL) at this anastomotic site. PATIENTS AND METHODS: Fifty-one patients who underwent TaTME for low rectal cancer from April 2021 to October 2022 were included. TaTME was performed by two teams, and reconstruction was performed by anastomosis with a single stapling technique (SST). After the anastomosis was thoroughly cleaned, Z sutures were placed parallel to the staple line to suture the mucosa on the oral and anal side of the staple line and to cover the staple line circumferentially. Data on operative time, Distal Margin (DM), recurrence and postoperative complications including AL were prospectively collected. RESULTS: The mean age of patients was 67 years. There were 36 males and 15 females. The overall mean operative time was 283.1 min, and the mean Distal Margin was 2.2 cm. Postoperative complications were observed in 5.9% of the patients, but no AL was observed, nor any serious complications with Clavien-Dindo ≥ 3 grade. Of the 49 cases excluding Stage 4, postoperative recurrence was observed in 2 cases (4.9%). CONCLUSION: In patients with lower rectal cancer who underwent TaTME, additional mucosal coverage of the anastomotic staple line by transanal manipulation after reconstruction may be associated with a reduction in the incidence of postoperative AL. Further studies including late anastomotic complications are needed.


Subject(s)
Laparoscopy , Rectal Neoplasms , Male , Female , Humans , Aged , Anastomotic Leak/etiology , Rectum/surgery , Pilot Projects , Rectal Neoplasms/surgery , Rectal Neoplasms/complications , Postoperative Complications/epidemiology , Laparoscopy/methods , Treatment Outcome
13.
Int J Colorectal Dis ; 38(1): 30, 2023 Feb 09.
Article in English | MEDLINE | ID: mdl-36757433

ABSTRACT

BACKGROUND: The extent of lymphadenectomy in patients with pT2 colorectal cancer (CRC) remains controversial. This study aimed to elucidate the effects of D3 and D2 lymph node dissection (LND) on survival in patients diagnosed with pT2 CRC. METHODS: This was a retrospective cohort study from a high-volume cancer center in Japan. From April 2007 to December 2020, 6273 patients with primary CRC were included in the study; among these, 616 patients diagnosed with pT2 CRC underwent radical colorectal resection. Propensity score matching (PSM) was applied to balance potential confounding factors, and a total of 104 matched pairs were extracted from the entire cohort. Independent risk factors associated with prognosis were determined by Cox regression analysis. The main outcome measures were overall survival (OS) and cancer-specific survival (CSS). RESULTS: Before PSM, there was a statistically significant difference across the cohort in OS and CSS (p = 0.000 and 0.013) between D3 and D2 LND groups; the estimated hazard ratio (HR) was 2.2 (95% confidence interval (CI), 1.1-4.4, p = 0.031) for OS in the D3 LND and 4.4 (95% CI, 1.7 to 11, p = 0.0027) for CSS (p = 0.013). There was also a significant difference (p = 0.024) in OS between the D3 and D2 LND groups in the matched cohort, with an estimated HR for OS of 3.3 (95% CI, 1.2 to 9.1, p = 0.024) and an estimated HR for CSS of 7.2 (95% CI, 1.6 to 33, p = 0.011). CONCLUSIONS: D3 LND had a significant survival advantage in the treatment of pT2 CRC. The results of this study provide a theoretical basis for the application of D3 LND in radical surgery for preoperative T2 CRC.


Subject(s)
Colorectal Neoplasms , Lymph Node Excision , Humans , Retrospective Studies , Neoplasm Staging , Lymph Node Excision/adverse effects , Prognosis , Colorectal Neoplasms/pathology , Lymph Nodes/surgery , Lymph Nodes/pathology
14.
Ann Gastroenterol Surg ; 7(1): 71-80, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36643354

ABSTRACT

Aim: Whether a laparoscopic procedure can contribute to the improvement of clinical outcomes in obese patients with stage II/III rectal cancer compared to an open procedure remains unclear. Objective: This study evaluated the technical and oncological safety of laparoscopic surgery versus open surgery in obese patients (body mass index [BMI] ≥25 kg/m2) with rectal cancer. Patients and Methods: Data were collected from patients with pathological stage II/III rectal cancer and analyzed. Operations were performed via laparoscopic or open surgery from 2009 to 2013. A comparative analysis was performed after applying propensity score matching to the two cohorts (laparoscopic group and open group). The primary endpoint was 3-y relapse-free survival (RFS). Results: Overall, 524 eligible cases were collected from 51 institutions. Equal numbers of propensity score-matched patients were included in the laparoscopic (n = 193) group and open (n = 193) group. Although the rate of D3 lymph node dissection did not differ between the laparoscopic group (87.0%) and the open group (88.6%), the median number of harvested lymph nodes was significantly lower in the laparoscopic group versus open group (17.5 vs 21, P = 0.0047). The median postoperative hospital stay was also significantly shorter in the laparoscopic group (14 d) vs the open group (17 d) (P = 0.0014). Three-y RFS was not significantly different between the two groups (hazard ratio 1.2454, 95% confidence interval 0.9201-1.6884, P = 0.4689). Conclusion: The short- and long-term results of this large cohort study (UMIN ID: UMIN000033529) indicated that laparoscopic surgery in obese rectal cancer patients has advantageous short-term outcomes and no disadvantageous long-term outcomes.

15.
J Surg Case Rep ; 2023(12): rjad675, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38164216

ABSTRACT

A 65-year-old man presented to our hospital with complaints of diarrhea. Computed tomography showed a fistula with the small intestine, and a single incision laparoscopic low anterior resection for rectum with D3 dissection and partial resection of the small intestine were performed. Lymph node dissection, including a part of the inflow vessel area, was also performed because lymph node swelling was observed in the mesentery of the small intestine around the fistula. Histopathological analysis revealed that the lymph nodes in the small intestine were positive for metastasis. The patient was a 61-year-old woman who presented to our hospital with a chief complaint of diarrhea. A partial resection of the small intestine, including resection of the left hemicolectomy and lymph node dissection around the fistula, was performed at laparotomy. Histopathological examination revealed numerous lymph node metastases in the small intestinal mesentery.

16.
Am Surg ; : 31348221146975, 2022 Dec 20.
Article in English | MEDLINE | ID: mdl-36539982

ABSTRACT

OBJECTIVE: To identify risk factors for lymph node metastasis and postoperative recurrence of pT1 colorectal cancer by clinicopathological study of surgically resected cases. METHODS: In 801 patients with pT1 colorectal cancer who underwent surgical resection with lymph node dissection between April 2007 and January 2021, we evaluated clinicopathological factors (age, gender, BMI, serum CEA level, tumor localization, additional resection after endoscopic treatment, operation time, blood loss, histological type, tumor size, vascular invasion, and central lymph node dissection). We performed univariate and multivariate analyses to examine risk factors for lymph node metastasis. We also examined risk factors for recurrence in 583 patients up to December 2017. RESULTS: Lymph node metastasis was observed in 100/801 patients (12.5%). Multivariate analysis of lymph node metastasis showed that patients with positive lymphatic invasion (odds ratio 2.57, 95% CI 1.62-4.04, P < .0001), positive venous invasion (odds ratio 2.31, 95% CI 1.48-3.61, P = .0002), and histologically poorly differentiated type (odds ratio 4.54, 95% CI 1.35-15.2, P = .014) were identified as risk factors. Postoperative recurrence was observed in 18/580 patients (3.1%). Risk factors for postoperative recurrence were also examined, including preoperative endoscopic treatment (odds ratio 3.59, 95% CI 1.18-10.9, P = .024), positive venous invasion (odds ratio 3.63, 95% CI 1.22-10.8, P = .021), positive lymph node metastasis (odds ratio 4.91, 95% CI 1.10-21.8, P = .037) were extracted as risk factors. DISCUSSION: In this study, venous invasion, lymphatic invasion, and histologically poorly differentiated type were identified as risk factors for lymph node metastasis in T1 colorectal cancer, and positive venous invasion, positive lymph node metastasis, and preoperative endoscopic treatment were identified as risk factors for recurrence. We hope that large prospective study will lead to the development of a more specific treatment strategy, including endoscopic treatment and additional surgical resection.

17.
Ann Gastroenterol Surg ; 6(4): 515-522, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35847436

ABSTRACT

Aim: The aim of this study was to compare the outcomes of GM142, a newly developed gelatin film with a concave and convex structure to a commercially available conventional film, hyaluronate-carboxymethylcellulose. Methods: Patients with primary rectal cancer who were scheduled for diverting ileostomy during laparoscopic surgery were eligible for this study. Patients were randomized before surgery and an antiadhesion film was applied under the umbilical incision. The primary outcome was the incidence of adhesion under the midline incision confirmed by second-look surgery for diverting ileostomy closure. The secondary outcomes were the adhesion severity score, the extent of adhesion score, the presence of intestinal obstruction, and the success of all patching. Results: A total of 146 patients were enrolled. A total of 123 patients were included in the full analysis set. The primary outcome of "no adhesion" was observed in 66.1% in the GM142 group and 55.7% in the conventional film group. The noninferiority of GM142 to conventional film was confirmed (P = .0005). The secondary outcomes were similar between the groups. For the safety evaluation, there were no safety concerns regarding allergic reactions to gelatin or increased gelatin-specific IgE antibody titers. Conclusions: The noninferiority of GM142 to conventional film was shown. GM142 showed no major safety issues. The clinical safety profiles of GM142 suggested certain physiological benefits of the gelatin film as an adhesion barrier.

18.
Jpn J Clin Oncol ; 52(11): 1270-1275, 2022 Nov 03.
Article in English | MEDLINE | ID: mdl-35863012

ABSTRACT

BACKGROUND: Successful achievement of randomized controlled trials (RCTs) is dependent on the acquisition of informed consent (IC) from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed acquisition of IC. METHODS: A 50-insitution RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage IV colon cancer (JCOG1107: UMIN-CTR 000000105). The success rate of obtaining IC was evaluated in eight periods between January 2013 and January 2021. In addition, reasons for failed acquisition of IC were identified from questionnaires. RESULTS: In total, 391 patients were informed of their eligibility for the trial, and 168 (42%) were randomly assigned to either the laparoscopic surgery group (n = 84) or open surgery group (n = 84). The success rate of IC acquisition ranged from 33 to 58% in three periods. The most common reasons for failed IC acquisition were the patients' preference for one approach of surgery based on recommendations from referring doctors and family members, and anxiety/unhappiness about randomization. CONCLUSIONS: The success rate of acquiring IC from patients for an RCT of laparoscopic versus open surgery for stage IV colon cancer was lower than the expected rate planned in the protocol. To obtain the planned rate, investigators should make efforts to inform patients and their families about the medical contributions a surgical RCT can make and recognize that the period in equipoise may be limited.


Subject(s)
Colonic Neoplasms , Laparoscopy , Rectal Neoplasms , Humans , Colonic Neoplasms/surgery , Informed Consent , Japan , Rectal Neoplasms/surgery
19.
Asian J Endosc Surg ; 15(3): 613-618, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35484860

ABSTRACT

BACKGROUND: The Senhance Digital Laparoscopy System (Asensus Surgical Inc, Morrisville, NC, United States), which was introduced for the first time in Japan by our hospital, is a new surgical assistive robot following the da Vinci Surgical System. We herein report the short-term outcomes of 55 colorectal cancer surgery cases using this system at our hospital to assess the feasibility and safety of our procedures. MATERIALS AND METHODS: We retrospectively reviewed the patient backgrounds and surgical outcomes of 55 patients who underwent Senhance-assisted laparoscopic colorectal cancer surgery. RESULTS: The median age was 71 years. There were 31 males and 24 females, and the median body mass index was 23.1 kg/m2 . Fifteen patients had a history of abdominal surgery. The most common surgical technique was ileocecal resection (18 cases, 32.7%), followed by high anterior resection (11 cases, 20.0%). D2 or D3 dissection was performed in each operation, and D3 dissection was performed in 41 cases (74.5%). The median operative time was 240 minutes, the median blood loss was 5 mL, there were no intraoperative complications, and there were no cases of intraoperative blood transfusion. The median postoperative hospital stay was 7 days, which was comparable to conventional laparoscopic surgery. Postoperative complications of grade 2 or higher in the Clavien-Dindo classification were observed in two cases. CONCLUSION: The short-term results of 55 colorectal cancer surgery cases using the Senhance Digital Laparoscopy System were excellent and the system was introduced and surgery was safely performed.


Subject(s)
Colorectal Neoplasms , Laparoscopy , Robotic Surgical Procedures , Robotics , Aged , Colorectal Neoplasms/surgery , Female , Humans , Laparoscopy/methods , Male , Retrospective Studies , Robotic Surgical Procedures/methods , Treatment Outcome
20.
Jpn J Clin Oncol ; 52(5): 456-465, 2022 May 05.
Article in English | MEDLINE | ID: mdl-35079828

ABSTRACT

BACKGROUND: Although the novel coronavirus disease 2019 did not lead to a serious medical collapse in Japan, its impact on treatment of oesophageal cancer has rarely been investigated. This study aimed to investigate the influence of the pandemic on consultation status and initial treatment in patients with primary oesophageal cancer. METHODS: A retrospective study was conducted among 546 patients with oesophageal cancer who visited our hospital from April 2018 to March 2021. Pre-pandemic and pandemic data were compared with the clinical features, oncological factors and initial treatment as outcome measures. RESULTS: Diagnoses of oesophageal cancer decreased during the early phase of the pandemic from April to June (P = 0.048); however, there was no significant difference between the pre-pandemic and pandemic periods throughout the year. The proportion of patients diagnosed with distant metastases significantly increased during the pandemic (P = 0.026), while the proportion of those who underwent initial radical treatment decreased (P = 0.044). The rate of definitive chemoradiotherapy decreased by 58.6% relative to pre-pandemic levels (P = 0.001). CONCLUSIONS: Patients may have refrained from consultation during the early phase of the coronavirus disease 2019 pandemic. The resultant delay in diagnosis may have led to an increase in the number of patients who were not indicated for radical treatment, as well as a decrease in the number of those who underwent definitive chemoradiotherapy. Our findings highlight the need to maintain the health care system and raise awareness on the importance of consultation.


Subject(s)
COVID-19 , Esophageal Neoplasms , COVID-19/epidemiology , Esophageal Neoplasms/epidemiology , Esophageal Neoplasms/therapy , Humans , Pandemics , Rare Diseases , Retrospective Studies , SARS-CoV-2 , Tokyo/epidemiology
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